K182389 is an FDA 510(k) clearance for the Sysmex XN-L Automated Hematology Analyzer. This device is classified as a Counter, Differential Cell (Class II - Special Controls, product code GKZ).
Submitted by Sysmex America, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on January 25, 2019, 143 days after receiving the submission on September 4, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220.
| 510(k) Number | K182389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 2018 |
| Decision Date | January 25, 2019 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKZ — Counter, Differential Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |